Efficacy & Safety of Fluoroquinolone-Based Brucellosis Regimens (BRUCE)

Summary

Brucellosis is a globally distributed zoonosis with persistent clinical management challenges. The World Health Organization(WHO)-recommended doxycycline-rifampin (DOX-RIF) dual regimen may drive rifampin-associated antimicrobial resistance across all brucellosis-endemic regions. Patients with osteoarticular brucellosis require long-term intravenous ceftriaxone triple therapy, which is linked to poor treatment adherence due to repeated hospital visits and outpatient care demands. Fluoroquinolones (levofloxacin \[LVX\], moxifloxacin \[MXF\]) exert excellent anti-Brucella activity and superior bone-joint penetration, yet high-quality multicenter prospective data comparing rifampin-sparing LVX-DOX/MXF-DOX dual regimens against standard RIF-DOX remain rarely reported. Existing comparative studies are limited to small single-center retrospective cohorts or trials pairing rifampin with fluoroquinolones rather than rifampin-free dual oral therapy. This multicenter prospective parallel-cohort protocol includes Module I (non-inferiority design) : 200 patients with uncomplicated acute brucellosis receiving 6-week dual oral therapy; and Module II (non-inferiority design) : 150 patients with imaging-confirmed osteoarticular brucellosis receiving 12-week triple therapy. Clinical data of standardized clinical, laboratory, radiologic, and subsequent longitudinal follow-up data will be collected via centralized electronic data capture. Primary endpoints include clinical and microbiological cure rates at 6 weeks (Module I) and 12 weeks (Module II). Secondary endpoints measure 24-week post treatment recurrence, 24- and 48-week radiologic improvement for osteoarticular disease, and adverse events during treatment. Multivariate regression and Cox models will identify independent prognostic factors and construct a generalizable recurrence risk prediction model. This clinical trial fills a critical evidence gap for oral fluoroquinolone-based regimens, with findings intended to supply supplementary brucellosis treatment approach, reduce rifampin resistance pressure, and eliminate reliance on prolonged parenteral therapy for complicated brucellosis.

Conditions

• Brucellosis
• Osteoarthritis

Interventions

DRUG

Doxycycline + Rifampicin

Standard first-line dual oral regimen recommended by WHO for brucellosis. Eligible patients with uncomplicated brucellosis take oral doxycycline combined with rifampicin continuously for an 8-week course.

DRUG

Doxycycline + Levofloxacin

Experimental dual oral regimen for uncomplicated brucellosis. Patients receive oral doxycycline combined with levofloxacin for a total of 8 weeks.

DRUG

Doxycycline + Moxifloxacin

Experimental dual oral regimen for uncomplicated brucellosis. Patients receive oral doxycycline combined with moxifloxacin for a total of 8 weeks.

DRUG

Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks)

Triple combined regimen for moderate-severe osteoarticular brucellosis. Patients take oral doxycycline and rifampicin continuously, plus 4 weeks of intravenous ceftriaxone infusion. The scheme targets complicated joint and bone lesions to strengthen antibacterial efficacy for severe cases.

DRUG

Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin)

Full-course oral triple regimen for brucellosis treatment. Patients continuously take oral doxycycline, rifampicin and levofloxacin for 8 weeks. This regimen boosts antibacterial potency against bone-joint brucellosis lesions and lowers rifampicin resistance risks compared with dual-drug schemes.

DRUG

Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin)

Full-course oral triple regimen for brucellosis therapy. Patients take oral doxycycline, rifampicin and moxifloxacin daily for an 8-week treatment cycle. Moxifloxacin delivers outstanding bone-joint tissue penetration, enhancing curative effects for osteoarticular brucellosis and reducing rifampicin resistance risks relative to dual-drug regimens.

Sponsors & Collaborators

• The Second People's Hospital of Yining, Xinjiang Uyghur Autonomous Region

  collaborator UNKNOWN

• Qitai Hospital of the Sixth Division, Xinjiang Production and Construction Corps

  collaborator UNKNOWN

• Yanqi Hospital of the Second Division, Xinjiang Production and Construction Corps

  collaborator UNKNOWN

• Sixth Division Hospital, Xinjiang Production and Construction Corps (Wujiaqu People's Hospital)

  collaborator UNKNOWN

• Xinhua Hospital of Ili Kazakh Autonomous Prefecture, Xinjiang

  collaborator UNKNOWN

• The First Affiliated Hospital of Shihezi University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-12-31

Completion

2027-12-31